FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

EMA Updates 18-Year-Old Guidelines for Cardiovascular Clinical Trials

Sept. 26, 2017
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The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018.

For acute coronary syndrome, the new guideline updates the definitions of ST-segment elevation myocardial infarction and unstable angina, and addresses risk stratification using different scoring systems, investigable trial endpoints and clinical development of new products beyond the acute stage, including agents other than antiplatelets and anticoagulants.

The new ACS guideline also defines several clinical trial endpoints, including: mortality, new myocardial infarction, non-fatal stroke, revascularization, unstable chest pain requiring hospitalization, stent thrombosis, and left ventricular function and heart failure.

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